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Official Course
Description: MCCCD Approval: 6-24-08 |
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CRC293
2008 Fall – 2010 Summer II |
LEC
3.0 Credit(s) 3.0 Period(s) 3.0 Load Occ |
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Clinical
Study Development |
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Introduction
to the Clinical Study Development Process and various roles of a Clinical
Research Associate (CRA). Roles and responsibilities of in-house CRA versus
Field CRA support, timelines of Clinical Study Development, overview of the
ABC model, drug versus device study development and national and
international considerations. Prerequisites: CRC290. |
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Go to Competencies Go to Outline
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MCCCD
Official Course Competencies: |
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CRC293 2008
Fall – 2010 Summer II |
Clinical Study Development |
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1.
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Present an overview of the timelines associated with
Clinical Study Development using the course model. (I) |
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2.
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Identify and describe the critical milestones/events of
study development. (I, II) |
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3.
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Describe the key personnel in the study design process.
(I, II) |
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4.
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Design a study plan timeline for a standard study
protocol. (I, IV) |
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5.
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Describe the specific roles and responsibilities of a CRA
in Clinical Study Development. (II, III) |
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6.
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Compare and contrast the study design role of the CRA
across therapeutic disciplines. (II, III, IV) |
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7.
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Describe the process for investigator-initiated research
study development. (III) |
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8.
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Compare and contrast global versus national timelines in
the study development process. (IV) |
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9.
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Compare and contrast the study development components of
drug versus device clinical trials. (IV) |
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10.
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Create a device study plan based on a study timeline. (IV)
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11.
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Present a risk management plan based on the implications
of functional group delays. (V) |
Go to Description Go to top of
Competencies
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MCCCD
Official Course Outline: |
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CRC293 2008
Fall – 2010 Summer II |
Clinical Study Development |
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I. Clinical Study
Development timelines A. Overview of the ABC
model B. A Phase: Assembly &
design phase C. B Phase:
Building/production phase D. C Phase: Carrying it
out/implementation phase E. Major milestones and
time points F. Feasibility II. Clinical Study
Development roles overview A. Functional groups; data
management, manufacturing, statisticians, regulatory, clinicians and finance B. In-house CRA versus
field CRA's C. Project Management D. Consultants and Clinical
Research Organizations (CRO's) III. Clinical Research
Associate roles in detail A. In House CRA: Design,
Production and Implementation Phase B. Regional CRA: Design,
Production and Implementation Phase C. Investigator-Initiated
Research IV. Development of plans A. Review of protocol
development B. Standard plans versus
therapeutic considerations C. Global versus national
requirements D. Device plans V. Resources necessary for
clinical study development A. Review of applicable
regulations B. Electronic systems
utilized C. Training (affiliate
training meetings, start-up meetings, etc.) D. Risk management |
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